Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives

Abstract

Stabilized pharmaceutical formulations of insulin analogs and/or insulin derivatives are disclosed.

The invention claimed is: 
     
       1. A pharmaceutical formulation consisting of:
 (a) 3.5 mg/mL insulin aspart; 
 (b) 1.72 mg/mL metacresol; 
 (c) 1.50 mg/mL phenol; 
 (d) 0.04087 mg/mL zinc chloride; 
 (e) 6.8 mg/mL sodium chloride; 
 (f) 0.02 mg/mL polysorbate 20; 
 (g) sodium hydroxide and/or hydrochloric acid to adjust the pH to 7.4, and 
 (h) water. 
 
     
     
       2. The pharmaceutical formulation according to  claim 1 , wherein the pharmaceutical formulation is an aqueous pharmaceutical formulation. 
     
     
       3. The pharmaceutical formulation as claimed in  claim 1 , wherein the pharmaceutical formulation is formulated for injection. 
     
     
       4. A kit comprising one or more separate packages of
 (a) the pharmaceutical formulation as claimed in  claim 1 ; and 
 (b) a medical device. 
 
     
     
       5. A kit comprising one or more separate packages of
 (a) the pharmaceutical formulation as claimed in  claim 1 ; and 
 (b) at least one further active pharmaceutical ingredient; 
 (c) and optionally a medical device. 
 
     
     
       6. The kit according to  claim 5 , wherein the further active pharmaceutical ingredient is an antidiabetic agent. 
     
     
       7. The kit as claimed in  claim 5 , wherein the further active pharmaceutical ingredient is an antidiabetic agent selected from the group consisting of:
 (a) a GLP-1 receptor agonist; 
 (b) a dual GLP-1 receptor/glucagon receptor agonist; 
 (c) human FGF-21; 
 (d) an FGF-21 analogue; 
 (e) an FGF-21 derivative; 
 (f) insulin; 
 (g) human insulin; 
 (h) an analogue of insulin; and 
 (i) a derivative of insulin. 
 
     
     
       8. A method of treating diabetes mellitus in a subject in need thereof comprising administering to said subject a therapeutically effective amount of the pharmaceutical formulation of  claim 1 . 
     
     
       9. A method of treating hyperglycemia in a subject in need thereof comprising administering to said subject a therapeutically effective amount of the pharmaceutical formulation of  claim 1 . 
     
     
       10. A method of lowering glucose levels in a subject in need thereof comprising administering to said subject a therapeutically effective amount of the pharmaceutical formulation of  claim 1 . 
     
     
       11. A medical device comprising the pharmaceutical formulation as claimed in  claim 1 , for administering the pharmaceutical formulation to an animal and/or human. 
     
     
       12. A process for preparing the pharmaceutical formulation according to  claim 1 , wherein the components are mixed together in the form of a solution or suspension, the pH is adjusted to reach pH 7.4, and water is added to reach the final volume.